Coated medical device product and process

ABSTRACT

Medical device products have a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660. Medical device processes use the medical device product having a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660.

PRIORITY

The present application is a non-provisional patent application claiming priority and benefit of U.S. Provisional Patent Application No. 63/074,859, filed Sep. 4, 2020 and entitled “COATED MEDICAL DEVICE PRODUCT AND PROCESS,” the entirety of which is incorporated by reference.

FIELD OF THE INVENTION

The present invention is directed to medical device products and processes using such medical devices. More particularly, the present invention is directed to such medical devices and processes requiring properties corresponding with NAMSA Class VI certification.

BACKGROUND OF THE INVENTION

NAMSA Class VI certification provides support for materials being biocompatible. Materials, such as certain parylene thin films and coatings are known to have such certifications. However, only alkylated parylenes are amorphous, thereby limiting applications. As a result of the coatings being semi-crystalline they scatter light and have limitations of use. Certain parylenes melt at temperatures of less than 300° C. Others anneal at temperatures of 400° C. and then degrade.

Coated medical device products and processes able to operate with expanded operating conditions would be desirable in the art.

BRIEF DESCRIPTION OF THE INVENTION

In an embodiment, a medical device product has a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660.

In an embodiment, a medical device process uses a medical device product having a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660.

Other features and advantages of the present invention will be apparent from the following more detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the invention.

DETAILED DESCRIPTION OF THE INVENTION

Provided are medical device products having a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660, which is hereby incorporated by reference. In addition, provided are medical device processes using such medical device products.

The Dursan® process, exclusively available from SilcoTek Corporation in the United States, was improperly identified as being incompatible with properties corresponding with NAMSA Class VI certification. Likewise, coatings disclosed in U.S. Pat. No. 10,604,660, entitled “WEAR RESISTANT COATING, ARTICLE, AND METHOD,” which is hereby incorporated by reference in its entirety, were improperly identified as being incompatible with NAMSA Class VI certification.

According to embodiments of the disclosure, the medical device product includes properties within the scope of U.S. Pat. No. 10,604,660, for example, having a carbon, hydrogen, oxygen, silicon in an amorphous arrangement. Suitable products include, but are not limited to, components capable of being produced into a coated article include, but are not limited to, gas storage vessels (for example, an article having an open end, a closed end, and a cylindrical portion between, an article having an open end and a spherical and/or round portion, such as, a gas cylinder or an air can), fittings (for example, unions, connectors, adaptors, other connections between two or more pieces of tubing, for example, capable of making a leak-free or substantially leak-free seal), compression fittings (including ferrules, such as, a front and back ferrule), tubing (for example, coiled tubing, tubing sections such as used to connect a sampling apparatus, pre-bent tubing, straight tubing, loose wound tubing, tightly bound tubing, and/or flexible tubing, whether consisting of the interior being treated or including the interior and the exterior being treated), valves (such as, gas sampling, liquid sampling, transfer, shut-off, or check valves, for example, including a rupture disc, stem, poppet, rotor, multi-position configuration, able to handle vacuum or pressure, a handle or stem for a knob, ball-stem features, ball valve features, check valve features, springs, multiple bodies, seals, needle valve features, packing washers, and/or stems), quick-connects, sample cylinders, regulators and/or flow-controllers (for example, including o-rings, seals, and/or diaphragms), injection ports (for example, for gas chromatographs), in-line filters (for example, having springs, sintered metal filters, mesh screens, and/or weldments), frits, columns, materials, glass liners, gas chromatograph components, liquid chromatography components, components associated with vacuum systems and chambers, components associated with analytical systems, sample probes, control probes, sampling containers, drilled and/or machined block components, manifolds, particles, powders, or a combination thereof.

In another embodiment, the medical device product or medical device process includes elements from one or more of the following patent applications, each of which are incorporated by reference in their entirety, and the medical device product or medical device process have operational properties outside the limitations such following patent applications:

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While the invention has been described with reference to one or more embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment disclosed as the best mode contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims. In addition, all numerical values identified in the detailed description shall be interpreted as though the precise and approximate values are both expressly identified. 

What is claimed is:
 1. A medical device product having a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660.
 2. The medical device product of claim 1, wherein the coating is on a fitting.
 3. The medical device product of claim 1, wherein the coating is on tubing.
 4. The medical device product of claim 1, wherein the coating is on a valve.
 5. The medical device product of claim 1, wherein the coating is on a filter.
 6. The medical device product of claim 1, wherein the coating is on a frit.
 7. The medical device product of claim 1, wherein the coating is on a probe.
 8. The medical device product of claim 1, wherein the coating is on metal.
 9. The medical device product of claim 1, wherein the coating is on glass.
 10. The medical device product of claim 1, wherein the medical device is a therapeutic device.
 11. The medical device product of claim 1, wherein the medical device is a wound care device.
 12. The medical device product of claim 1, wherein the medical device is a catheter.
 13. The medical device product of claim 1, wherein the medical device is an interrogator.
 14. The medical device product of claim 1, wherein the medical device is positioned within a human.
 15. The medical device product of claim 1, wherein the medical device is a surgical instrument.
 16. The medical device product of claim 1, wherein the medical device is a perfusion device.
 17. The medical device product of claim 1, wherein the medical device is a gastric bypass device.
 18. The medical device product of claim 1, wherein the medical device is a drug delivery device.
 19. The medical device product of claim 1, wherein antibodies are in contact with the coating.
 20. A medical device process uses a medical device product having a coating with NAMSA Class VI certification and properties corresponding to the prior art coatings within U.S. Pat. No. 10,604,660. 